TRACHEOSTOMY TUBE AND TUBE CUFF

TRACHEOSTOMY TUBE AND TUBE CUFF is an FDA 510(k)-cleared medical device (K924660) manufactured by Applied Medical Resources. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 10, 1992. Regulation: 8.